Stroke Circulatory System Stroke
Conditions
Interventions
Patients will be randomised into one of two groups- the intervention or non-intervention group
this randomisation will be computer generated and stratified according to the National Institute of Health Stroke Score (NIHSS)
patients will be allocated according to their arm score- group score of 1/2 or 3/4.
Tipstim glove –the intervention.
The glove (various sizes) will be applied onto the
Sponsors
Countess of Chester Hospital NHS Foundation Trust
BHR Pharmaceuticals (United Kingdom)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 years or over 2. Male and female 3. Unilateral stroke (both ischaemic and haemorrhagic) with sensory motor arm/hand weakness (2 days to 2 weeks) post stroke 4. Baseline National Institute of Health Stroke Scale (NIHSS) arm motor score of 1-4 5. Pre-stroke modified Rankin Scale (mRS) of 0-3 6. Signed informed consent or witnessed verbal consent
Exclusion criteria
Exclusion criteria: 1. Patients with transient ischemic attack with symptoms lasting less than 24 hours 2. No arm weakness 3. History of epilepsy 4. Patients with permanent pacemaker 5, Aphasia, or cognitive impairment that prevented completion of the baseline assessment 6. Patients with dermatitis or oedema of the affected hand Inclusion in another research study, including another randomised controlled trial, does not automatically exclude a patient from participating in this trial. As long as inclusion in the other study would not confound the results of this trial, co-enrolment will be permissible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change (improvement) in upper limb function at three months using the Action Research Arm Test score 2. Change (improvement) in upper limb function at three months using the Fugl-Meyer assessment of upper extremity (FMA-UE) test 3. Change (improvement) in upper limb function at three months using the Nine Hole Peg test) test 4. Safety incidence for intervention (RSS) group only: 4.1.Any damage to the skin of the hand including necrosis, ulcers occurring within 30 days of enrolment 4.2.Reasons for prematurely stopping the RSS 4.3.Epileptic seizures 4.4.Painful shoulder in the affected side 4.5.Spasticity or contractures of the affected hand 5. Users’ feedback (intervention group only): User’s feedback will be collected by organising user’s feedback meeting after approximately 10 patients have been through the two weeks of treatment. Altogether four meetings will be organised to gather their feedback. Their feedback will be collected by a semi-structured questionnaire covering the following themes: 5.1.How did they feel about using the RSS? 5.2.How easy was it to use? 5.3.Positive aspects of RSS 5.4.Negative aspects of RSS 5.5.Carers perspective on using RSS- perceived levels of spouse/patient improvement 5.6.Measures of outcomes- plus user perceived levels of improvement- psychological, physical, sensory 5.7.Overall impressions of RSS-would they carry on using it if offered and would they recommend it? All outcomes are measured at baseline and then again at 2 weeks and 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change (improvement) in daily living activities, assessed using the Nottingham Extended Activities of Daily Living (NEADL) score (intervention group only) 2. Change (improvement) of quality of life, assessed using the EUROQoL 5D questionnaire (intervention group only) 3. Change (improvement) in mood, assessed using the BASDEC - Brief Assessment Schedule Depression Cards score (intervention group only) All outcomes are measured at baseline and then again at 2 weeks and 3 months. | — |
Countries
England, United Kingdom
Outcome results
None listed